Breast CancerPhase 2NCT03703492
Hybrid Molecular Imaging of ER in Breast Cancer Patients With DCIS
A Phase 2 study testing (18F)FES and Gadobenate dimeglumine in people with Breast Cancer and Ductal Carcinoma in Situ - Category, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
This prospective, one-arm study which will enroll participants with biopsy-proven DCIS scheduled for diagnostic breast MRI for preoperative staging/extent of disease evaluation as part of standard of care. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Ductal Carcinoma in Situ - Category
- What is being tested?
- (18F)FES and Gadobenate dimeglumine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2019to 2 Jan 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of biopsy-proven DCIS without invasion or microinvasion measuring at least 1.0 cm in diameter by any imaging modality
- Undergoing diagnostic breast MRI ordered by the referring clinician for staging and extent of disease
Who cannot join
- Inability or unwillingness to provide informed consent to the study
- Surgery, radiation, neoadjuvant chemo/endocrine therapy for the current malignancy prior to study enrollment
- Participants currently taking or have taken an ER-blocking medication (e.g. tamoxifen, raloxifene) within 6 weeks prior to study enrollment
- Pregnant or lactating women
- Participant with intolerance or contraindications for MRI or gadolinium-based contrast agents
- Participant girth exceeds the bore of the MRI/PET scanner
Show all 12Show fewer
- Participants with a history of allergic reaction attributable to compounds of similar chemical or biologic composition to 18F-FES
- Participants in liver failure as judged by the patient's physician, due to the hepatobiliary clearance of 18F-FES
- Participants requiring intravenous (IV) conscious sedation for imaging are not eligible; participants requiring mild, oral anxiolytics for the clinical MRI will be allowed to participate as long as the following criteria are met:
- The participant has their own prescription for the medication
- The informed consent process is conducted prior to the self-administration of this medication
- They come to the research visit with a driver or an alternative plan for transportation (e.g. Uber, taxi, etc.)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53705
About this study
Official title: Positron Emission Tomography/Magnetic Resonance Imaging of Estrogen Receptor Expression n Non-Invasive Breast Cancer
This prospective, one-arm study which will enroll participants with biopsy-proven DCIS scheduled for diagnostic breast MRI for preoperative staging/extent of disease evaluation as part of standard of care. Eligible participants will be consented for participation in the research study which includes a directed breast PET/MRI with 18F-FES. 18F-FES uptake of the known malignancy will be measured on the PET/MRI examination using standardized uptake values (SUV) and tumor-to-normal tissue ratios.
Read the detailed description
Integrated whole-body magnetic resonance imaging (MRI)-positron emission tomography (PET) scanners have recently been introduced for clinical use. This technology combines the anatomic and perfusion data obtained with Dynamic Contrast Enhanced (DCE) MRI with functional imaging data obtained from PET. For breast imaging, the combination of MRI and PET has important potential to improve diagnostic accuracy and provide molecular characterization of breast cancer. The overall purpose of this research is to determine the technical feasibility of simultaneous breast DCE MRI with 18F-FES PET for measuring estrogen receptor (ER) in patients with ductal carcinoma in situ (DCIS) and identifying patients with low-risk of disease recurrence. The hypothesis is that quantitative 18F-FES uptake parameters from PET/MRI will correlate well with the ER immunohistochemistry score and with low-risk recurrence scores.
Primary Objective 1) To compare quantitative 18F-FES uptake of biopsy-proven DCIS measured using PET/MRI with ER protein levels determined by immunohistochemistry.
Secondary Objectives
- To determine the optimal cut-point 18F-FES uptake value for distinguishing between ER+ and ER-negative DCIS
- To determine the test-retest reproducibility of quantitative assessment of tumor 18F-FES uptake
- To determine the optimal cut-point 18F-FES uptake value for distinguishing between low-risk DCIS and intermediate/high-risk DCIS
- To estimate the association of quantitative 18F-FES uptake (continuous SUVmax) with research-based Oncotype DX DCIS scores (0-100)
- To measure the upgrade rate to invasive cancer at surgical excision
- To correlate tumor 18F-FES uptake with serum estradiol and sex hormone binding globulin levels.
Exploratory Objective
- To correlate tumor cell density with 18F-FES uptake on PET/MRI
- Conditions
- Breast Cancer, Ductal Carcinoma in Situ - Category
- Being tested
- (18F)FES, Gadobenate dimeglumine
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(18F)FESDrug
Also called 11.2 16α-[18F]-fluoro-17β-estradiol, FES
18F-FES is an investigational new drug which will be used for this study. For complete information, please refer to the Investigator's Brochure: "[18F]Fluoroestradiol: An investigational positron emission tomography (PET) radiopharmaceutical for injection, intended for use as an in vivo diagnostic for imaging estrogen receptors in tumors
Gadobenate dimeglumineDrug
Also called MultiHance
Gadolinium-based intravenous contrast agent used for the MRI portion of this study
| Study group | Role | What they receive |
|---|---|---|
| Research Arm | Experimental | Directed breast PET/MRI with 18F-FES; 18F-FES uptake of the known malignancy to be measured on the PET/MRI examination Receives: Drug: (18F)FES; Drug: Gadobenate dimeglumine |
What is being measured
The primary outcome is the main question the study is designed to answer.
18F-FES Uptake in DCIS
18F-FES uptake of biopsy-proven ductal carcinoma in situ (DCIS) measured using PET/MRI will be reported in Standardized Uptake Values (SUV).
Measured: 1 day
Secondary outcomes (5)
Prognostic Risk Categories Determined Using Van Nuys Prognostic Index, the MSKCC Nomogram
ROC curve analysis will be performed to determine the optimal cut-point for 18F-FES SUVmax to distinguish low-risk DCIS and intermediate/high-risk DCIS. Risk categories will be determined using the Van Nuys Prognostic Index, the Memorial Sloan-Kettering Cancer Center Nomogram, and the research-based Oncotype DX DCIS score. Sensitivity and specificity will be determined with two-sided 95% confidence intervals. The area under the curve (AUCs) for the ROCs and their respective two-sided 95% confidence intervals will be calculated using logistic regression.
The optimal cut-off point will be determined by considering the 18F-FES uptake value with the maximum sensitivity and specificity.
This analysis will be done separately for each risk assessment model.
Measured: 2 months
Research-based Oncotype DX DCIS Scores
To estimate the association of quantitative 18F-FES uptake (continuous SUVmax) with research-based Oncotype DX DCIS scores (0-100), scatter plots of continuous quantitative 18F-FES uptake (SUVmax) on the y-axis and research-based Oncotype DX DCIS scores (unitless) on the x-axis will be created to explore the distribution of the measurements. Pearson's or Spearman's rank correlation will be used to evaluate the association between quantitative 18F-FES uptake and research-based Oncotype DX DCIS score. The correlation coefficient (rho) and 95% confidence interval will be reported.
Measured: 12 months
Number of Participants With Invasive Cancer at Surgical Excision
This percentage will be calculated by dividing the number of patients with invasive breast cancer diagnosed at the time of surgical excision by the number of patients with percutaneous biopsy-proven DCIS in the study.
Measured: 2 months
Serum Estradiol Levels
Mean serum estradiol levels will be reported to summarize the outcome measure.
Measured: 1 day
Serum Sex Hormone Binding Globulin Levels
A correlation analysis of sex hormone binding globulin levels will be performed using Pearson's or Spearman's rank correlation. Scatter plots, correlation coefficients (rho) and 95% confidence intervals will be reported.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2018
- Study start3 Jan 2019
- Primary completion2 Jan 2024
- Study completion2 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a prospective, one-arm, observational study which will enroll participants with biopsy-proven DCIS scheduled for diagnostic breast MRI for preoperative staging/extent of disease evaluation as part of standard of care.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor
- Investigators
- Amy Fowler, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03703492
- Sponsor's protocol ID
- UW18063
- Other IDs
- KL2TR000428, NCI-2018-02281, 2018-0814, A539300, SMPH/RADIOLOGY/RADIOLOGY, P30CA014520, Protocol Version 5/11/2022
- Status last verified
- Feb 2025
- First submitted
- 9 Oct 2018
- Last updated
- 12 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positron Emission Tomography/Magnetic Resonance Imaging of Estrogen Receptor Expression n Non-Invasive Breast Cancer
- ClinicalTrials.gov ID
- NCT03703492
- Acronym / sponsor ID
- UW18063
- Conditions
- Breast Cancer, Ductal Carcinoma in Situ - Category
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Center for Advancing Translational Sciences (NCATS)
- Study start
- 3 Jan 2019 (actual)
- Primary completion
- 2 Jan 2024 (actual)
- Study completion
- 2 Jan 2024 (actual)
- First posted
- 12 Oct 2018 (actual)
- Results
- Posted 12 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective, one-arm study which will enroll participants with biopsy-proven DCIS scheduled for diagnostic breast MRI for preoperative staging/extent of disease evaluation as part of standard of care. Eligible participants will be consented for participation in the research study which includes a directed breast PET/MRI with 18F-FES. 18F-FES uptake of the known malignancy will be measured on the PET/MRI examination using standardized uptake values (SUV) and tumor-to-normal tissue ratios.
Detailed description
Integrated whole-body magnetic resonance imaging (MRI)-positron emission tomography (PET) scanners have recently been introduced for clinical use. This technology combines the anatomic and perfusion data obtained with Dynamic Contrast Enhanced (DCE) MRI with functional imaging data obtained from PET. For breast imaging, the combination of MRI and PET has important potential to improve diagnostic accuracy and provide molecular characterization of breast cancer. The overall purpose of this research is to determine the technical feasibility of simultaneous breast DCE MRI with 18F-FES PET for measuring estrogen receptor (ER) in patients with ductal carcinoma in situ (DCIS) and identifying patients with low-risk of disease recurrence. The hypothesis is that quantitative 18F-FES uptake parameters from PET/MRI will correlate well with the ER immunohistochemistry score and with low-risk recurrence scores.
Primary Objective 1) To compare quantitative 18F-FES uptake of biopsy-proven DCIS measured using PET/MRI with ER protein levels determined by immunohistochemistry.
Secondary Objectives
- To determine the optimal cut-point 18F-FES uptake value for distinguishing between ER+ and ER-negative DCIS
- To determine the test-retest reproducibility of quantitative assessment of tumor 18F-FES uptake
- To determine the optimal cut-point 18F-FES uptake value for distinguishing between low-risk DCIS and intermediate/high-risk DCIS
- To estimate the association of quantitative 18F-FES uptake (continuous SUVmax) with research-based Oncotype DX DCIS scores (0-100)
- To measure the upgrade rate to invasive cancer at surgical excision
- To correlate tumor 18F-FES uptake with serum estradiol and sex hormone binding globulin levels.
Exploratory Objective
- To correlate tumor cell density with 18F-FES uptake on PET/MRI
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a prospective, one-arm, observational study which will enroll participants with biopsy-proven DCIS scheduled for diagnostic breast MRI for preoperative staging/extent of disease evaluation as part of standard of care.
| Arm | Type | Receives |
|---|---|---|
| Research Arm | Experimental | Drug: (18F)FES, Drug: Gadobenate dimeglumineDirected breast PET/MRI with 18F-FES; 18F-FES uptake of the known malignancy to be measured on the PET/MRI examination |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of biopsy-proven DCIS without invasion or microinvasion measuring at least 1.0 cm in diameter by any imaging modality
- Undergoing diagnostic breast MRI ordered by the referring clinician for staging and extent of disease
Key exclusion criteria (12 listed)
- Inability or unwillingness to provide informed consent to the study
- Surgery, radiation, neoadjuvant chemo/endocrine therapy for the current malignancy prior to study enrollment
- Participants currently taking or have taken an ER-blocking medication (e.g. tamoxifen, raloxifene) within 6 weeks prior to study enrollment
- Pregnant or lactating women
- Participant with intolerance or contraindications for MRI or gadolinium-based contrast agents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| (18F)FESAlso: 11.2 16α-[18F]-fluoro-17β-estradiol, FES18F-FES is an investigational new drug which will be used for this study. For complete information, please refer to the Investigator's Brochure: "[18F]Fluoroestradiol: An investigational positron emission tomography (PET) radiopharmaceutical for injection, intended for use as an in vivo diagnostic for imaging estrogen receptors in tumors | Drug | Research Arm |
| Gadobenate dimeglumineAlso: MultiHanceGadolinium-based intravenous contrast agent used for the MRI portion of this study | Drug | Research Arm |
Primary outcome
18F-FES Uptake in DCIS
Time frame: 1 day
18F-FES uptake of biopsy-proven ductal carcinoma in situ (DCIS) measured using PET/MRI will be reported in Standardized Uptake Values (SUV).
5 secondary outcomes
Prognostic Risk Categories Determined Using Van Nuys Prognostic Index, the MSKCC Nomogram
Time frame: 2 months
Research-based Oncotype DX DCIS Scores
Time frame: 12 months
Number of Participants With Invasive Cancer at Surgical Excision
Time frame: 2 months
Serum Estradiol Levels
Time frame: 1 day
Serum Sex Hormone Binding Globulin Levels
Time frame: 1 day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of Wisconsin Carbone Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amy Fowler principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing (18F)FES and Gadobenate dimeglumine in people with Breast Cancer and Ductal Carcinoma in Situ - Category, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
18F-FES Uptake in DCIS (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2025.